Second method for using cannula including a valve structure and associated instrument elements

ABSTRACT

According to the present invention, an outer hollow cannula including a valve structure is adapted to receive inner instrument elements for performing the procedures of thoracentesis and plueral biopsy. The cannula comprises: a hollow cylindrical body including a longitudinally directed circular lumen; proximal attachment means; and the valve structure being interposed along the length of the cannula lumen. The valve structure includes a cylindrical member being interposed perpendicularly along the path of the cannula lumen, being rotatable about an axis perpendicular to the longitudinal direction of the cannula lumen, and further includes a short lumen having the same diameter as the cannula lumen and being rotatable to be concentric with the cannula lumen or being rotatable to be perpendicular to the cannula lumen. For performing the thoracentesis procedure, the cannula also comprises a distal circular annular surface. The cannula is adapted to receive an inner hollow needle instrument element including proximal attachment means, a location surface marker, and a distal slanted elliptical annular surface. For performing the pleural biopsy procedure, the cannula also comprises a distal tapered circular sharp edge. The cannula is adapted to receive an inner solid stylet instrument element and an inner hollow cutting needle instrument element. The stylet includes proximal attachment means, a location surface marker, and a distal symmetrical tapered pointed edge. The cutting needle includes: proximal attachment means, a proximal location surface marker, a distal location surface marker, distal sharp edge cutting means, and a distal circular annular surface.

FIELD OF THE PRESENT INVENTION

This invention relates to medical and surgical instruments and inparticular to a method for using a cannula including a valve structureand associated instrument elements for performing the procedures ofpleural biopsy and thoracentesis.

OTHER RELATED APPLICATIONS

This application is a continuation-in-part application of copendingapplication Ser. No. 07/097,098, filed 9/16/88, and entitled "CannulaIncluding A Valve Structure And Associated Instrument Elements AndMethod For Using Same" by the same applicant herein.

DISCUSSION OF THE PRIOR ART

The prior art discloses several medical and surgical instrumentsincluding valve structures such as:

a. Tyrrell U.S. Pat. No. 1,086,873 entitled "Syringe" discloses a devicecomprising an axially perforated conoidal head, a stop pin, a injectiontube, connecting means, a rotary tapering valve stem, holding means, anda second pin;

b. Hevern U.S. Pat. No. 1,740,174 entitled "Embalmer's Trocar" disclosesa device comprising an elongated tube, a trocar point, a pipe, threebranch pipes, a valve, and a manually operated pipe;

c. Kahn U.S. Pat. No. 2,482,622 entitled "Self-Retaining UterineCannula" discloses such a cannula comprising a tubular shaft, a valve, asealing acorn, an acorn stop, a tenaculum control member, and a thumbring limiting member;

d. Hamilton U.S. Pat. No. 3,434,691 entitled "Valve" discloses such avalve comprising a body of plastic material, a rigid housing, a plastictapered plug valve member, and resilient means;

e. Bucalo U.S. Pat. No. 3,777,737 entitled "Method And Device ForReversibly Interrupting Fluid Flow In A Living Being" discloses a valvecomprising an elongated valve housing, movable means, barrier means, andfilamentary means;

f. Walbillig U.S. Pat. No. 3,783,900 entitled "Stop Cock" discloses amedical valve comprising a generally cylindrical cup-shaped body, aplug, cooperating means, and a stiffening element;

g. Topham U.S. Pat. No. 3,957,052 entitled "Pumping-Syringe" disclosessuch a syringe comprising a barrel, a plunger, a valving structure, afirst ball valve seat, a second ball valve seat, a first ball valve, asecond ball valve, and a cannula;

h. Villari U.S. Pat. No. 4,051,852 entitled "Aspirating Device"discloses such a device comprising: a valve assembly including a firstport, a second port, a passageway, one-way valve means, a third port, asecond passageway, and second one-way valve means; port means; and pumpmeans; and

i. Stim U.S. Pat. No. 4,187,849 entitled "Suction Curettage Device WithValve Control And Support Means For Differing Diameter Tubes" disclosessuch a device comprising a housing and a suction tube support member.

It is apparent that the cited prior art patents do not disclose thecannula including the valve structure and associated instrument elementsof the present invention for performing the procedures of a pleuralbiopsy and thoracentesis.

Objects of the present invention are therefore:

a. to provide a valve structure that is adaptable for performing eithera pleural biopsy or a thoracentesis procedure;

b. to provide such a valve structure that allows communication with thepleural cavity for performing either a pleural biopsy or a thorcentesisprocedure and to minimize the risk of a pneumothorax;

c. to provide such a valve structure that allows the deletion oraddition of instrument elements through the proximal end of the cannuladuring the performing of either a pleural biopsy or a thoracentesisprocedure while the cannula remains inserted into the pleural cavity;

d. to provide such a cannula including the valve structure that isadaptable to the insertion and extraction of various instrument elementsthrough its proximal end; and

e. to provide such a cannula including the valve structure that isadaptable to the attachment of syringe or other vacuum means at itsproximal end.

SUMMARY AND FEATURES OF THE PRESENT INVENTION

A summary and features of the present invention are that:

a. an outer hollow cannula including a two-position valve structure isadapted to receive inner instrument elements for performing theprocedures of thoracentesis and plueral biopsy;

b. such cannula comprises a hollow cylindrical body including alongitudinally directed circular lumen, proximal attachment means, andsuch valve structure being interposed along the length of such cannulalumen; such valve structure including a cylindrical member beinginterposed perpendicularly along the path of such cannula lumen andbeing rotatably about an axis perpendicular to the longitudinaldirection of such cannula lumen, and also including a short lumen havingthe same diameter as such cannula lumen and being rotatable to beconcentric with such cannula lumen or being rotatable to beperpendicular to such cannula lumen;

c. for performing the thoracentesis procedure, such cannula alsocomprises a distal circular annular surface and is adapted to receive aninner hollow needle instrument element including proximal attachmentmeans, a location surface marker, and a distal slanted ellipticalannular surface;

d. for performing the pleural biopsy procedure, such cannula alsocomprises a distal tapered circular sharp edge and is adapted to receivean inner solid stylet instrument element and an inner hollow cuttingneedle instrument element; such stylet including proximal attachmentmeans, a location surface marker, and a distal symmetrical taperedpointed edge; and such cutting needle including proximal attachmentmeans, a proximal location surface marker, a distal location surfacemarker, distal sharp edge cutting means, and a distal circular annularsurface;

e. such valve structure is in the open position when such associatedinstrument element is in the fully inserted position within suchcannula; and

f. such valve structure is in the closed position when such associatedinstrument element is fully extracted from such cannula.

Advantages of the present invention are therefore that:

a. the cannula including the valve structure is adaptable to receiveinstrument elements used for performing either a pleural biopsy or athoracentesis procedure;

b. the cannula including the valve structure may be utilized forperforming either a pleural biopsy or a thoracentesis procedure withouthaving to remove the cannula from the pleural cavity during therespective procedure;

c. use of the cannula including the valve structure lessens theprobability of pneumothorax during the respective procedure;

d. the cannula including the valve structure is adaptable for use withrespect to any part of the body where it is desirable to avoid leakageof gas or fluid into or from the body during the respective procedure;

e. use of the cannula including the valve structure does not requiresignificant patient cooperation or significant physician skill forperforming the respective procedure;

f. the cutting needle instrument element in combination with the cannulacan be used with relative safety and will provide high yield in mostpatients including less cooperative patients and those with less pleuralfluid; and

g. use of the cannula including the valve structure in combination withthe stylet and the cutting needle instrument elements significantlyreduces the complication of pneumothorax.

DESCRIPTION OF THE DRAWING

The above and other objects, features, and advantages of the presentinvention will be better appreciated from a reading of the followingdetailed description in conjunction with the drawing in which:

FIG. 1 is a cross-sectional side view of a cannula including its valvestructure in the open position and being adapted to perform athoracentesis procedure according to the present invention;

FIG. 2 is a partially cross-sectional side view of the needle includingits associated syringe to be used in conjunction with the cannula ofFIG. 1;

FIG. 3 is a cross-sectional side view of the needle of FIG. 2 beingfully inserted into the cannula of Figure 1 including the valvestructure in the open position;

FIG. 4 is a partially cross-sectional side view of the needle of FIG. 2being partially extracted or partially inserted relative to the cannulaof FIG. 1 including the valve structure in the closed position;

FIG. 5 is a cross-sectional side view of the cannula of FIG. 1 includingthe valve structure in the open position and having its associatedsyringe attached thereto;

FIG. 6 is a cross-sectional side view of another cannula including itsvalve structure in the open position and being adapted to perform apleural biopsy procedure according to the present invention;

FIG. 7 is a partially cross-sectional side view of the stylet to be usedin conjunction with the cannula of FIG. 6;

FIG. 8 is a partially cross-sectional side view of the stylet of FIG. 7being partially inserted or partially extracted relative to the cannulaof FIG. 6 including the valve structure in the closed position;

FIG. 9 is a cross-sectional side view of the stylet of FIG. 7 beingfully inserted into the cannula of Figure 6 including the valvestructure in the open position;

FIG. 10 is a partially cross-sectional side view of the cutting needleto be used in conjunction with the cannula of FIG. 6;

FIG. 11 is a partially cross-sectional side view of the cutting needleof FIG. 10 being partially inserted or partially extracted relative tothe cannula of FIG. 6 including the valve structure in the closedposition;

FIG. 12 is a cross-sectional side view of the cutting needle of FIG. 10being fully inserted into the cannula of FIG. 6 including the valvestructure in the open position; and

FIG. 13 is a partially cross-sectional side view of the cutting needleof FIG. 10 being inserted into the cannula of FIG. 6 and the cannulabeing in its further advanced position relative to the cutting needleand including the valve structure in the open position.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

During a thoracentesis procedure, a catheter or needle is positionedinto the pleural cavity of a patient between the parietal and viscerallayers of the pleura to remove a collection of body fluid which may bein the pleural cavity due to a number of reasons, such as infection,heart failure, or cancer. Various devices are provided for aspiratingthe fluid from the pleural cavity through the catheter or needle.

A thoracentesis is the procedure during which fluid located in thepleural cavity is extracted for testing and analysis thereafter. Thetapping of pleural fluid is a relatively safe, simple, and commonly usedprocedure in medical practice. Numerous devices, both homemade andcommercially available, are used for such purpose. However, the successof the procedure depends on patient cooperation and physician skill. Acommonly feared complication of the procedure is a pneumothoraxresulting either secondary to laceration of the lung surface with thesharp edge of a needle or from the sucking of air from a less than airtight system. Since the pleural cavity has a negative pressure relativeto atmospheric pressure, it is predisposed to the sucking of air into itif the system or technique used is not airtight. A thoracentesis needleshould have the following features: the distal end or the part insertedinto the chest cavity should be blunt to avoid accidental laceration ofthe lung surface by over penetration with the needle, by expansion ofthe lung by the patient during coughing, or by the repositioning of thelung if the patient were to suddenly move; the outer portion of theneedle should be simple to operate and should provide an effective sealto keep air from entering the pleural cavity; and the needle should beeconomical to manufacture.

FIG. 1 is a cross-sectional side view of outer cannula 10 includingvalve structure 21 in the open position and being adapted to perform athoracentesis procedure according to the present invention. FIG. 1 showscannula 10 including: distal longitudinally directed cylindrical hollowportion 11 with lumen 18 and further including distal end 14; proximallongitudinally directed cylindrical hollow portion 12 with lumen 19 andfurther including proximal end 13 with mechanical attachment means 22and frictional attachment means 20; and intermediate valve structure 21including transverse cylindrical rotating member 15 with lumen 23,rotating means 16, and means 17 for securing valve structure 21 toportions 11 and 12. Portion 11 may be about three inches long; portions11 and 12 may be made of fourteen gauge material; cannula 10 may beabout five and one-half inches long; and proximal end 13 includingmechanical attachment means 22 and frictional attachment means 20 may beof the so-called Luer-Lok type being adaptable to accept a syringe,stopcock, or drainage attachments. The open position occurs when valvestructure lumen 23 is coincident and continuous with cannula lumens 19and 18. Distal end 14 is of the blunt annular circular type.

FIG. 2 is a partially cross-sectional side view of inner needle 30including associated syringe 38 attached thereto to be used inconjunction with cannula 10 of Figure 1. FIG. 2 shows needle 30including: distal longitudinally directed cylindrical hollow portion 31with lumen 36 and further including location surface marker 35, distalend 34, and proximal end 32 with mechanical attachment means 37 andfrictional attachment means 33; and syringe 38 further including distalattachment means 39. Portion 31 may be about six inches long and may bemade of sixteen gauge material; distal end 34 may be a so-called bevelpointed or slanted annular elliptical end and may be about one-eighth ofan inch long; and proximal end 32 may be of the so-called Luer-Lok type.

FIG. 3 is a cross-sectional side view of needle 30 of FIG. 2 being fullyinserted into cannula 10 of FIG. 1 including valve structure 21 in theopen position. FIG. 3 shows: portion 11 including distal end 14 insertedthrough chest wall 100 and into pleural cavity 101; portion 31 includingdistal end 34 also inserted through chest wall 100 and into pleuralcavity 101; valve structure 21 including rotating means 16 in the openposition; portion 12 including proximal end 13; and syringe 38 includingdistal end 39 attached to proximal end 32.

FIG. 4 is a partially cross-sectional side view of needle 30 of FIG. 2being partially extracted or partially inserted relative to cannula 10of FIG. 1 including valve structure 21 in the closed position. Theclosed position occurs when valve structure lumen 23 is perpendicular toand not continuous with cannula lumens 19 and 18. FIG. 4 shows: portion11 including distal end 14 inserted through chest wall 100 and intopleural cavity 101; valve structure 21 including rotating means 16 inthe closed position; portion 12 including proximal end 13; portion 31including distal end 34 inserted into portion 12, location surfacemarker 35 just being visible proximally, and proximal end 32; andsyringe 38 including distal end 39 attached to proximal end 32.

FIG. 5 is a cross-sectional side view of cannula 10 of FIG. 1 includingvalve structure 21 in the open position and having syringe 38 attachedthereto. FIG. 5 shows: portion 11 including distal end 14 insertedthrough chest wall 100 and into pleural cavity 101; valve structure 21including rotating means 16 in the open position; portion 12 includingproximal end 13; and syringe 38 including distal end 39 attached toproximal end 13.

FIG. 6 is a cross-sectional side view of outer cannula 40 includingvalve structure 52 in the open position and being adapted to perform apleural biopsy procedure according to the present invention. FIG. 6shows cannula 40 including: distal longitudinally directed cylindricalhollow portion 45 with lumen 46 and further including distal end 47;valve structure 52 further including rotating means 48, transversecylindrical rotating member 49 with lumen 51, and means 50 for attachingvalve structure 52 to portions 45 and 41; and proximal longitudinallydirected cylindrical hollow portion 41 with lumen 44 and furtherincluding proximal end 42 with attachment means 43 and frictionalattachment means 144. Portion 45 may be about three inches long and mayinclude external surface markers spaced about 1/2 inch apart forlocating the portion of cannula 40 relative to pleural cavity 101;portion 41 may be about one and one-half inches long; portions 45 and 41may be made of eleven gauge material; proximal end 42 may be ofso-called Leur-Lok type; and distal end 47 may be a tapered circular endwith a sharp cutting edge.

FIG. 7 is a partially cross-sectional side view of inner stylet 60 to beused in conjunction with cannula 40 of FIG. 6. FIG. 7 shows stylet 60including: distal longitudinally directed cylindrical solid portion 61further including location surface marker 64 and distal end 65; andproximal end 62 further including attachment means 63. Portion 61 may bemade of thirteen gauge material and may be about six inches long; anddistal end 65 may be of the so-called symmetrical trocar point type.

FIG. 8 is a partially cross-sectional side view of stylet 60 of FIG. 7being partially inserted or partially extracted relative to cannula 40of FIG. 6 including valve structure 52 in the closed position. FIG. 8shows: portion 45 including distal end 47 inserted through chest wall100 and into pleural cavity 101; valve structure 52 including rotatingmeans 48 in the closed position; portion 41 including proximal end 42;portion 61 including distal end 65 inserted into portion 41, locationsurface marker 64 just being visible proximally, and proximal end 62further including attachment means 63.

FIG. 9 is a cross-sectional side view of stylet 60 of FIG. 7 being fullyinserted into cannula 40 of FIG. 6 including valve structure 52 in theopen position. FIG. 9 shows: portion 45 including distal end 47 insertedthrough chest wall 100 and into pleural cavity 101; valve structure 52including rotating means 48 in the open position; portion 41 includingproximal end 42; and proximal end 62 including attachment means 63.

FIG. 10 is a partially cross-sectional side view of inner cutting needle70 to be used in conjunction with cannula 40 of FIG. 6. FIG. 10 showscutting needle 70 including: distal longitudinally directed cylindricalhollow portion 71 with lumen 72 and further including proximal locationsurface marker 73, distal location surface marker 74, distal end 77, andcurved lateral cutting edge 78; and proximal end 75 including cuttingedge location marker 79, frictional attachment means 76, and mechanicalattachment means 78. Portion 71 may be made of thirteen gauge materialand may be about five and one-half inches long; cutting edge 78 may beof the so-called sharp hooking snare type; and distal end 77 may of thecircular annular type.

FIG. 11 is a partially cross-sectional side view of cutting needle 70 ofFIG. 10 being partially inserted or partially extracted relative tocannula 40 of FIG. 6 including valve structure 52 in the closedposition. Figure 11 shows: portion 45 including distal end 47 insertedthrough chest wall 100 and into pleural cavity 101; valve structure 52including rotating means 48 in the closed position; portion 41 includingproximal end 42; portion 71 including distal end 77 and cutting edge 78being inserted into portion 41, distal location surface marker 74 justbeing visible proximally, proximal location surface marker 73, andproximal end 75 with mechanical attachment means 78 being attached todistal end 104 of syringe 103.

FIG. 12 is a cross-sectional side view of cutting needle 70 of FIG. 10being fully inserted into cannula 40 of FIG. 6 including valve structure52 in the open position. FIG. 12 shows: portion 45 including distal end47 inserted through chest wall 100 and into pleural cavity 101; valvestructure 52 including rotating means 48 in the open position; portion41 including proximal end 42; portion 71 including both distal end 77and cutting edge 78 just being visible distally; and proximal end 75including mechanical attachment means 78 being attached to distal end104 of syringe 103.

FIG. 13 is a partially cross-sectional side view of cutting needle 70 ofFIG. 10 inserted into cannula 40 of FIG. 6 and cannula 40 being in itsfurther advanced position relative to cutting needle 70 and includingvalve structure 52 in the open position. FIG. 13 shows: portion 45including distal end 47 inserted through chest wall 100 in its furtheradvanced position to again cover distal end 77 and cutting edge 78having the biopsied tissue attached thereto; valve structure 52including rotating means 48 in the open position; portion 41 includingproximal end 42; portion 71 including proximal location surface marker73 just being visible proximally; and proximal end 75 includingmechanical attachment means 78 attached to distal end 104 of syringe103.

The valve structure and associated instrument elements required foreffecting the thoracentesis procedure according to the present inventioncomprises: an outer hollow cannula including a valve structure; and aninner hollow needle for fitting into such cannula as tight as possible.In the open position of the valve structure, the cannula lumen isconcentric with the valve structure lumen; while in the closed positionof the valve structure, the valve structure lumen is perpendicular tothe cannula lumen.

For performing the thoracentesis procedure according to the presentinvention, the patient is prepped in the usual manner and thethoracentesis site is determined. A local anesthesic is then applied.Thereafter, a one millimeter incision may made with a number elevenscalpel to help facilitate penetration of the cannula-needle combinationinto the chest wall. The overall structure in the pre-penetrationconfiguration comprises: cannula 10 including valve structure 21 in theopen position; needle 30 being fully inserted therethrough such thatneedle distal end 34 is just distal to cannula distal end 14; andsyringe 38 being attached to needle proximal end 32. Distal ends 34 and14 are then advanced through chest wall 100 and into pleural cavity 101while needle 30 is aspirated with syringe 38. Once outward pleural fluidflow is encountered and achieved, cannula 10 is further advancedappoximately 1/2 to 1 centimeter into pleural cavity 101 to cover distalend 34 of needle 30. See FIG. 3. Then, with cannula 10 well secured inplace, needle 30 is slowly withdrawn or extracted from cannula 10 whilegentle aspiration of the fluid is maintained with syringe 38. Thisextraction process is continued until approximately the distal twoinches of needle 30 is located in the proximal two inches of cannula 10.This can be assured via location surface marker 35 which is correctlylocated on the outer surface of needle 30 and is just visible proximallyin this position. This is done to assure that distal end 34 is not stillinside or distal to valve structure 21. At this time, valve structure 21is placed in the closed position in order to occlude distal portion 11of cannula 10. See FIG. 4. The procedure so far eliminates theprobability of allowing an air leak into pleural cavity 101. At thistime, needle 30 can be fully withdrawn from cannula 10 without therebeing a leak into pleural cavity 101. The pleural fluid so far collectedin syringe 38 can be tested and analyzed. Cannula 10 can now bemaintained inserted into pleural cavity 101 with valve structure 21 inthe closed position. Inserted cannula 10 including valve structure 21 inthe closed position can now be utilized alternatively as follows: alarge syringe 38 may be attached to proximal end 13 of cannula 10; valvestructure 21 may then be placed in the open position; and then largeamounts of fluid may be aspirated from chest cavity 101. See FIG. 5.Once such aspiration procedure is completed, valve structure 21 isplaced in the closed position and syringe 38 may be removed or detachedfrom proximal end 13 of inserted cannula 10. This procedure can berepeated as many times as necessary. Alternatively, intravenous tubingcan be attached to proximal end 13 of inserted cannula 10 includingvalve structure 21 in the closed position; the tubing must be clampedcompletely; an associated vacuum bottle is then pierced with the needleassociated with the other end of the intravenous tubing; valve structure21 is placed in the open position and such tubing is unclamped. Fluidwill now flow automatically into the vacuum bottle and the flow can becontrolled by the extent of clamping of the intravenous tubing. It willbe apparent that this overall procedure can also be useful for theinstilling of sclerosing agents or chemotherapeutic agents into chestcavity 101. At the completion of the overall procedure, inserted cannula10 is then pulled out from pleural cavity 101 and the puncture site isclosed using antibacterial ointment and adhesive bandages.

Several biopsy needles are available for the taking of percutaneousbiopsy samples of the pleura. None of these available biopsy needlesprovides both high yield and safety. The present instrument providessuch advantages with relative simplicity. Since the pleural cavity isunder negative pressure, it is of utmost importance that an airtightsystem be provided. The biopsy medical instrument according to thepresent invention comprises: an outer hollow cannula including a valvestructure; an inner solid stylet; and an inner hollow cutting needle.The valve structure includes a rotating valve member with a throughlumen which is perpendicular to the axis of rotation of the rotatingvalve member and which through lumen can be rotated to be perpendicularto the cannula lumen into the closed position or can be rotated to beconcentric with the cannula lumen into the open position. The diameterof the cannula lumen is equal to the diameter of the rotating valvemember lumen. The stylet is adaptable to fit completely into the cannulaexcept for its proximal end which is adapted to fit into the cannulaproximal end. The stylet includes a sharp symmetrical distal end whichis adapted to coincide with the sharp distal end of the cannula. Thecutting needle is adapted to fit into the cannula with about onecentimeter of the cutting needle distal end being exposable beyond thedistal end of the cannula. Such exposed cutting needle distal endincludes an annular circular cross-section and just proximal to suchdistal end it includes the functional lateral cutting edge. The mostproximal end of the cutting needle internally includes a cylindricalsurface which is adaptable to frictionally receive the distal end of asyringe with or without mechanically locking onto same. The cuttingneedle proximal end also includes laterally extending means for locatingand coordinating the rotated angular position of the needle cuttingedge. The cutting needle also includes proximal and distal locationsurface markers on its external surface for cuing the longitudinalposition of the cutting needle along the cannula lumen. The stylet andthe cutting needle both include location surface markers to indicatethat each element when inserted into the cannula is just proximal to thelocation of the cannula valve structure while the cutting needle aloneincludes a location surface marker to indicate that the cutting needledistal end is immediately adjacent to the cannula distal end. Thecannula also includes attachment means at its proximal end to allow theattachment of a syringe or intravenous tubing to drain fluid from thepleural cavity. The distal 3 inches of the cannula may include markersbeing about 1/2 inch apart to help locate the position of the cannularelative to the pleural cavity.

The steps for performing the pleural biopsy procedure according to thepresent invention are as follows. The appropriate intercostal space forthe pleural biopsy is identified. The location of such space isconfirmed by draining fluid using a syringe with a needle. Afterapplying adequate local anesthesia to the penetration site, a cut ismade on the skin and the subcutaneous tissue with a size eleven scalpel.The cut should be big enough to allow entry of the pleural biopsy needleinto the pleural space. In the initial insertion step, the combinationcomprising cannula 40 including valve structure 52 in the open positionand stylet 60 inserted therein is inserted into the cut and into thepleural space. See FIG. 9. Once the pleural space is reached, thencannula 40 with valve structure 52 in the open position is held in placewhile stylet 60 is extracted until location surface marker 64 on stylet60 is just visible proximally. See FIG. 8. This indicates that distalend 65 of stylet 60 is just proximal to valve structure 52. At thistime, valve structure 52 is placed in the closed position so that thereis no further communication of distal portion 45 of cannula 40 with theatmosphere. This configuration allows for an effective seal from theatmosphere. Stylet 60 is now completely extracted from cannula 40. Next,cutting needle 70 is inserted into cannula 40 until distal locationsurface marker 74 on cutting needle 70 is just visible proximally.Inserted cutting needle 70 and its associated syringe 103 provide aneffective seal in this configuration. See FIG. 11. Now, valve structure52 is placed in the open position and cutting needle 70 is pushedcompletely into cannula 40 until distal end 77 of cutting needle 70 isdistal to distal end 47 of cannula 40. Proximal cutting edge locationmarker 79 is immediately adjacent to proximal end 42. See FIG. 12. Next,some pleural fluid is suctioned into attached syringe 103 to make surethat distal end 77 of cutting needle 70 is in pleural space 101. Next,cutting edge 78 of cutting needle 70 is hinged against the adjacentparietal pleura and some more pleural fluid is suctioned with syringe103 to make sure that distal end 77 of cutting needle 70 is in pleuralspace 101. Next, cannula 40 is slid forward with cutting needle 70 beingheld in place manually relative to the parietal pleura until proximallocation surface marker 73 of cutting needle 70 is just visibleproximally thereby indicating that distal end 47 of cannula 40 fullycovers distal end 77 of cutting needle 70. During this step, the pieceof parietal pleura that is cut off remains stuck within cutting edge 78of cutting needle 70. See FIG. 13. Next, cutting needle 70 is extractedenough from cannula 40 so that distal location surface marker 74 ofcutting needle 70 is just visible proximally. Valve structure 52 is thenplaced in the closed position thereby closing the communication ofdistal portion 45 of cannula 40 to the atmosphere. See FIG. 11. Next,cutting needle 70 is fully withdrawn from cannula 40 and the biopsiedpleural tissue is removed from cutting edge 78 and is placed in anappropriate receptacle.

While the arrangement according to the present invention has beendescribed in terms of a specific illustrative embodiment, it will beapparent to those skilled in the art that many modifications arepossible within the spirit and scope of the disclosed principle.

What is claimed is:
 1. A method for penetrating external body tissue andfor taking a sample of internal body tissue being located below suchexternal body tissue, said method comprising the steps of:a. penetratingsuch external body tissue with a cannula-stylet combination, saidcombination comprising an outer hollow cannula and an inner solidstylet; said cannula including a valve structure, a proximal endportion, and a distal end portion; said cannula distal end portion beinglonger than said cannula proximal end portion and said valve structurecombined; said cannula distal end portion further including asymmetrically tapered circular sharp edge; said stylet including aproximal end portion and a distal end portion; said stylet distal endportion further including a location surface marker and a symmetricallytapered pointed edge; said valve structure being in the open positionand said stylet distal end portion being located just distal to saidcannula distal end portion; b. withdrawing said stylet from said cannulawhile maintaining said cannula distal end portion located within suchinternal tissue until said stylet distal end portion location surfacemarker is located just proximal to said cannula proximal end portionwhereby said stylet distal end portion is located just proximal to saidvalve structure; c. placing said valve structure in the closed position;d. fully withdrawing said stylet from said cannula; e. inserting aninner hollow needle-syringe combination into said cannula; said needleincluding a proximal end portion and a distal end portion; said needleproximal end portion further including a location surface marker; saidneedle distal end portion further including a location surface marker,sharp lateral edge cutting means, and a circular annular surface; saidsyringe being attached to said needle proximal end portion; wherein saidneedle distal end portion location surface marker is located justproximal to said cannula proximal end portion whereby said needle distalend portion is located just proximal to said valve structure and withinsaid cannula proximal end portion; f. placing said valve structure inthe open position; g. inserting said needle until said proximal endportion location surface marker is located immediately adjacent to thecannula proximal end, whereby said needle distal end portion protrudesbeyond said cannula distal end; h. aspirating any fluid being locatedjust proximal to such internal tissue using said syringe being attachedto said needle proximal end portion; i. obtaining a piece of suchinternal tissue using said needle distal end portion sharp lateral edgecutting means while further aspirating such fluid using said syringebeing attached to said needle proximal end portion; j. advancing saidcannula distally relative to said needle such that said needle distalend portion is covered by said cannula distal end portion; k.withdrawing said needle from said cannula until said needle proximal endlocation surface marker is located just proximal to said cannulaproximal end portion whereby said needle distal end portion is justproximal to said valve structure; l. placing said valve structure in theclosed position; and m. fully withdrawing said needle including suchpiece of attached internal tissue from said cannula having said valvestructure in the closed position.